APSI Project: research and development of a Robot Assistant for the Preparation of Injectable Solutions (APSI)
2 BioTOM S.A., 19, rue du Bel Air, 91090 Lisses, France
3 Department of Informatic System, Institut Gustave Roussy, 39 rue C. Desmoulins, 94805 Villejuif, France
4 SCEA IFR 54, Institut Gustave Roussy, 39 rue C. Desmoulins, 94805 Villejuif, France
5 CF Conseil, 2, bd Albert 1er, 94130 Nogent sur Marne, France
Application to chemotherapy in the clinical setting
Injectable chemotherapeutic agents are often required in cancer treatment: an arsenal of high added value medications with intrinsic toxicity to which patients as well as operators handling these drugs are exposed.
Conventional preparation systems (clean air hoods or isolators) are however fallible. At the end of serious thought which began in 1998-1999, we considered that personnel and environmental exposures were no longer tolerable. Finally, the APSI Research and Development (R&D) programme: a Robot Assistant for the Preparation of Injectable Solutions, was born in February 2001. Our objectives were not only to answer the needs of the Institut Gustave Roussy (IGR), one of the very first leading research and anticancer centres.
Applying robotics to the preparation process was a venture aimed at creating a solid and flexible machine able to:
- eliminate risks of toxicity by preserving operators and the environment,
- manage the toxic waste more efficiently,
- eliminate human-related errors,
- optimise production costs,
- guaranteeing the tracability of TOs (Therapeutic Objects) e.g. bags, syringes,
- enhance the quality of the process,
- increase the production rate,
- comply with regulatory requirements.
In 2004, prescription processing in our Department of Clinical Pharmacy (DCP) gave rise to ≈ 38,000 TOs. In 2007, the DCP will generate ≈ 65,000 TOs per year. The APSI program is funded by a co-development exclusivity contract between IGR via its DCP and BioTOM S.A., a High-Tech industrial partner. The Project Group (pharmacists, engineers, technicians) operates in a concurrent engineering context according to 15 items:
- rapid prototyping and, direct production,
- virtual validation,
- mechanical confinement,
- electromechanics and, robotics,
- peri-robotics logistics,
- Man-Machine Interface development,
- development of a specific supervisor at the interface with APSI and computerised patient prescriptions,
- study of burden, simulation and management of drug preparation,
- process performance analysis and, qualification,
- cost evaluation and business plan.
After 30 months, the prototype is in the operational qualification phase. We are launching the production of the first of 3 machines designed to equip the future DCP production unit (January 2007). We feel that we have overcome practically all the technical stumbling blocks: the milestone schedule has been followed. APSI is a “technological breakthrough” and the result of a model hospital-industry partnership with an R&D budget totalling 1.8 M€.